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Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019473
First Posted: November 25, 2009
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
November 19, 2009
November 25, 2009
September 23, 2011
November 2009
August 2011   (Final data collection date for primary outcome measure)
Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score. [ Time Frame: Baseline to day 28 ]
Same as current
Complete list of historical versions of study NCT01019473 on ClinicalTrials.gov Archive Site
  • Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ]
  • Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients [ Time Frame: Day 1 to day 46 ]
  • Safety and tolerability of AFQ056 in Huntington's disease patients [ Time Frame: Day 1 to day 46 ]
  • Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ]
  • Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients [ Time Frame: Day 1 to day 46 ]
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Titration Proof of Concept Study in Patients With Huntington's Disease to Assess the Efficacy, Safety and Tolerability of AFQ056 in Reducing Chorea
This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize standard therapy in patients that have Huntington's disease in reducing chorea.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Huntington's Disease
  • Chorea
  • Drug: AFQ056
  • Drug: Placebo
  • Experimental: AFQ056A
    Intervention: Drug: AFQ056
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Reilmann R, Rouzade-Dominguez ML, Saft C, Süssmuth SD, Priller J, Rosser A, Rickards H, Schöls L, Pezous N, Gasparini F, Johns D, Landwehrmeyer GB, Gomez-Mancilla B. A randomized, placebo-controlled trial of AFQ056 for the treatment of chorea in Huntington's disease. Mov Disord. 2015 Mar;30(3):427-31. doi: 10.1002/mds.26174. Epub 2015 Feb 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
Not Provided
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10
  • patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
  • female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception

Exclusion Criteria:

  • patients with marked cognitive impairment (MMSE less than 18), with presence of psychosis and/or confusional states
  • patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
 
NCT01019473
CAFQ056A2207
2009-011743-39
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP